Research Ethics

Question 1

Research Ethics

Answer 1

Rules of conduct; ensure sound, logical practices; important consideration for research design development (how recruit participants, how often tested) one risk may not be the same for another

Question 2

Tuskegee Study

Answer 2

untreated syphilis in >400 African AMerican men. participants not informed of condition, antibiolotics not offered to participants

Question 3

Violation of Tuskegee Study

Answer 3

inform consent, non-educated participants, not told of treatment options,

Question 4

Monster Study

Answer 4

study of dysfluencies in children who stuttered and were fluent (what were effects of labeling someone as a stutterer), children in an orphanage, caregivers would react in a certain way when children had interruptions

Question 5

Violations in Monster Study

Answer 5

violation of human rights (deception and not substancial reason to support deception), varied views on this study because no long-lasting effects on the child vs. increased dysfluencies.

Question 6

Nazi Medical Atrocities

Answer 6

World War II- experimentation on concentration camp prisoners without consent

Question 7

What happened in response to these events?

Answer 7

1) Nuremburg Code
2) Establishment of the institutional Review Boards (IRB)
3) Belmont Report

Question 8

Nuremburg Code

Answer 8

Adopted in 1947- free choice- coluntary particpation of human subjects in research

Question 9

IRB

Answer 9

independent review bodies, ensure welfare (before and after) of participants in research, statement of approval:method section

Question 10

Belmont Report

Answer 10

Foundation for conduct of research in the US/world, constituted byt the National Commission for the Protection of Human Subjects of Biomedical and Behavioral research,
There are 3 basic ethical principles: respect for persons, beneficience, and justice.

Question 11

Respect for Persons

Answer 11

respect and honor decisions, human sunjects: autonomous agents, (exercise free will, informed consent, willing volunteers) consent form- explanation of research (materials, procedures, benefits and harm, privacy and confidentiatlity, contact info, no obligation, readable language, sign/date)

Question 12

Barriers to informed consent

Answer 12

vulnerable participants-children, prosoners, instiutionalized, pregnant/nursing mothers, proxy consent from caregivers, compensation for children, if using deception…always have good rationale and give truth right after.

Question 13

Beneficence

Answer 13

protect people from harm, maximize possible benefits and minimize possible harm, benefits- something of value to the participants, benefits > harm

Question 14

Justice

Answer 14

fair and unbiased selection of participants, fair and unbiased distribution of benefits, equal treatment of people in society, no convenience sampling,

Question 15

Declaration of Helsinki

Answer 15

World Medical Association: “ethical principles for medical research involving human subjects, inlcuding research on identifiable human material and data.”

Question 16

Animals in Research

Answer 16

Instiutional animal care and use committee (IACUC), for CSD- use animal models to simulate the use of tools and devices in speech, language, and hearing mechanisms.

Question 17

Responsible Conduct of Research (RCR)

Answer 17

1) research misconduct
2) Treatment of Data
3) Mistakes and Negligence
4) Randomize or not to randomize
5) Particpation in Clinical Research
6) questionable research practice: salami publishing
7) Questionable research practices: cherry picking

Question 18

Research Misconduct

Answer 18

Fabrication (making up data, making up results), Falsification (manipulating materials/methods, inaccurately representing data) plagiarism, (when in doubt, CITE)

Question 19

Treatment of Data

Answer 19

Permanent record, replication of work, ideally: Fundamental obligtion to maintain “accurate, accessible, and permanent record” (give it when asked) Way to implement- online secure permanent notebook, regular lab meetings, keep data and analysis in one folder and back up monthly

Question 20

Mistakes of Negligence

Answer 20

not sloppy work, researchers are human, there are consequences for carelessness,

Question 21

randomize or not to randomize

Answer 21

randomize is the gold standard of research, clinical equipoise: aske researcher if honest disagreement about treatment methods,
Freedman- “an honest disagreement among expert clinicians about the preffered treatment, honest null hypothesis- really truly sure if one isn’t better, research design- include clinical equipoise at begining experiemnt, Randomized Clincial Trial (RCT)- comparing unproven interventions to be considered ehtical: clinical equipoise before students are randomized, Declaration of Helsinki- everything (risks, burdens, effectiveness) must be tested against the best current proven intervention (not witholding therapy)

Question 22

Participation in Clinical Research

Answer 22

Discontinue partocaiption, integrity of inormed consent, protection from therapeautic misconception (this is not treatment but rather participation) compensation- has to be ethical. Declaration of Helsinki- stop study when risks outweigh the benefits, ASHA- “hold paramount the welfare of persons,” always keep best interst at hand, recuriting clients are participation can be very expensive and not a routine therapy session.

Question 23

Questionable Research practice: salami publishing

Answer 23

break down into least publishing units, increase one’s publication record (if cohesive with others should be published as 1)

Question 24

Questionable research practices: cherry picking

Answer 24

Selectively reporting data…favorable to the invetogator’s bias or point of view, pick results you want to publish, reporting data that only agrees with previous literature, weak research design, potentially misleading (withholding info)

Question 25

effects of misconduct

Answer 25

lost time, damage reputation, feelings of personal betrayal, consequences (can’t really have an active research job now)

Question 26

Researcher in society (why important?)

Answer 26

expert opinion in subject area, advice to organizations: educational, government, private companies, risk-benefit assessment, education (what we read)- can we believe this? Is this applicable?